Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan

Background: There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030. Aim: To assess if an integrated care package can achieve better control of diabetes. Design & setting: The pragmatic cluster randomised controlled t...

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Main Authors: Muhammad Amir Khan, John D Walley, Nida Khan, Joseph Hicks, Maqsood Ahmed, Shaheer Ellahi Khan, Muhammad Ahmar Khan, Haroon Jehangir Khan, Anthony D Harries
Format: Article
Language:English
Published: Royal College of General Practitioners 2018-12-01
Series:BJGP Open
Online Access:https://bjgpopen.org/content/2/4/bjgpopen18X101618
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author Muhammad Amir Khan
John D Walley
Nida Khan
Joseph Hicks
Maqsood Ahmed
Shaheer Ellahi Khan
Muhammad Ahmar Khan
Haroon Jehangir Khan
Anthony D Harries
author_facet Muhammad Amir Khan
John D Walley
Nida Khan
Joseph Hicks
Maqsood Ahmed
Shaheer Ellahi Khan
Muhammad Ahmar Khan
Haroon Jehangir Khan
Anthony D Harries
author_sort Muhammad Amir Khan
collection DOAJ
description Background: There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030. Aim: To assess if an integrated care package can achieve better control of diabetes. Design & setting: The pragmatic cluster randomised controlled trial (cRCT) was conducted from December 2014–June 2016 at 14 primary healthcare facilities in Sargodha district. Opportunistic screening, diagnostic testing, and patient recording processes were introduced in both the control 'testing, treating, and recording' (TTR) arm, and the intervention 'additional case management' (ACM) arm, which also included a clinical care guide and pictorial flipbook for lifestyle education, associated clinician training, and mobile phone follow-up. Method: Clinics were randomised on a 1:1 basis (sealed envelope lottery method) and 250 patients recruited in the ACM arm and 245 in the TTR-only arm (age ≥25 years and HbA1c >7%). The primary outcome was mean change in HbA1c (%) from baseline to 9-month follow-up. Patients and staff were not blinded. Results: The primary outcome was available for n = 238/250 (95.2%) participants in the ACM arm and n = 219/245 (89.4%) participants in the TTR-only arm (all clusters). Cluster level mean outcome was -2.26 pp (95% confidence intervals [CI] = -2.99 to -1.53) for the ACM arm, and -1.44 pp (95% CI = -2.34 to -0.54) for the TTR-only arm. Cluster level mean ACM–TTR difference (covariate-unadjusted) was -0.82 pp (95% CI = -1.86 to 0.21; P = 0.11). Conclusion: The ACM intervention in public healthcare facilities did not show a statistically significant effect on HbA1c reduction compared to the control (TTR-only) arm. Future evaluation should assess changes after a longer follow-up period, and minimal care enhancement in the comparator (control) arm.
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spelling doaj.art-8182c8d3e48b4161ab80f5f2d2b694c32022-12-22T02:43:25ZengRoyal College of General PractitionersBJGP Open2398-37952018-12-012410.3399/bjgpopen18X101618Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in PakistanMuhammad Amir Khan0John D Walley1Nida Khan2Joseph Hicks3Maqsood Ahmed4Shaheer Ellahi Khan5Muhammad Ahmar Khan6Haroon Jehangir Khan7Anthony D Harries8Association for Social Development, Islamabad, PakistanNuffield Centre for International Health and Development, Leeds Institute of Health Sciences, Leeds, UKAssociation for Social Development, Islamabad, PakistanNuffield Centre for International Health and Development, Leeds Institute of Health Sciences, Leeds, UKAssociation for Social Development, Islamabad, PakistanHumanities and Social Sciences Department, Bahria University, Islamabad, PakistanAssociation for Social Development, Islamabad, PakistanDirectorate General of Health Services, Lahore, PakistanDepartment of Research, International Union Against Tuberculosis and Lung Disease, Winchester, UKBackground: There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030. Aim: To assess if an integrated care package can achieve better control of diabetes. Design & setting: The pragmatic cluster randomised controlled trial (cRCT) was conducted from December 2014–June 2016 at 14 primary healthcare facilities in Sargodha district. Opportunistic screening, diagnostic testing, and patient recording processes were introduced in both the control 'testing, treating, and recording' (TTR) arm, and the intervention 'additional case management' (ACM) arm, which also included a clinical care guide and pictorial flipbook for lifestyle education, associated clinician training, and mobile phone follow-up. Method: Clinics were randomised on a 1:1 basis (sealed envelope lottery method) and 250 patients recruited in the ACM arm and 245 in the TTR-only arm (age ≥25 years and HbA1c >7%). The primary outcome was mean change in HbA1c (%) from baseline to 9-month follow-up. Patients and staff were not blinded. Results: The primary outcome was available for n = 238/250 (95.2%) participants in the ACM arm and n = 219/245 (89.4%) participants in the TTR-only arm (all clusters). Cluster level mean outcome was -2.26 pp (95% confidence intervals [CI] = -2.99 to -1.53) for the ACM arm, and -1.44 pp (95% CI = -2.34 to -0.54) for the TTR-only arm. Cluster level mean ACM–TTR difference (covariate-unadjusted) was -0.82 pp (95% CI = -1.86 to 0.21; P = 0.11). Conclusion: The ACM intervention in public healthcare facilities did not show a statistically significant effect on HbA1c reduction compared to the control (TTR-only) arm. Future evaluation should assess changes after a longer follow-up period, and minimal care enhancement in the comparator (control) arm.https://bjgpopen.org/content/2/4/bjgpopen18X101618
spellingShingle Muhammad Amir Khan
John D Walley
Nida Khan
Joseph Hicks
Maqsood Ahmed
Shaheer Ellahi Khan
Muhammad Ahmar Khan
Haroon Jehangir Khan
Anthony D Harries
Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
BJGP Open
title Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
title_full Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
title_fullStr Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
title_full_unstemmed Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
title_short Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
title_sort effectiveness of an integrated diabetes care package at primary healthcare facilities a cluster randomised trial in pakistan
url https://bjgpopen.org/content/2/4/bjgpopen18X101618
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